Not Applicable
Not Applicable
Not Applicable
(1) Field of the Invention
The present invention relates to ostomy devices of the type adapted to be adhesively affixed to the skin surrounding the stoma and more particularly to such a device which includes external means for controlling evacuation by sealing the stoma while exerting only a minimum amount of sealing pressure.
Certain surgical procedures known as colostomy, ileostomy and urostomy result in an opening in the abdominal wall, called a stoma, which permits waste discharge from the interior of a body cavity. Since the patient has no control over the waste discharge, it is often necessary for the patients who have undergone these surgical procedures to utilize an ostomy device to protect the stoma and collect the waste material as it is discharged.
Over the years, ostomy devices of a variety of different types and constructions have been utilized. Various materials and adhesives have been developed to increase the utility and wareability of the devices.
(2) Description of Related Art
The basic ostomy device includes a collection receptacle or pouch connected to an adhesive coated faceplate which serves to mount the pouch to the body. The pouch includes first and second thin film walls which are sealed by heat welding or the like along the periphery. The pouch has an inlet opening designed to be aligned with the stoma and an outlet for emptying material from the pouch. In single piece devices, the pouch is permanently affixed to the adhesive coated faceplate. In two piece devices, the pouch is detachably mounted to the faceplate by coupling rings or the like, permitting the pouch to be replaced without removal of the faceplate each time.
The two piece device requires a means for releasably mounting the pouch to the faceplate. One particularly successful structure takes the form of a pair of annular or ring-like rigid or semi-rigid plastic parts, one in the form of an axially extending rib and the other in the form of a channel into which the rib may be removably received and frictionally engaged.
These ostomy devices collect waste as it is discharged but include no means for controlling when discharge takes place. One of the main objectives of these devices is to increase the freedom of mobility of the wearer and thus the wearer""s ability to lead a normal life by participating in various activities. However, having discharge take place into the collection pouch in certain situations may cause embarrassment to the wearer because of the noise or smell or because of the increase in the size of the pouch.
Accordingly, it is desirable to control when evacuation takes place so that it does not occur at times which may cause embarrassment. Since the patient has no means to control waste discharge, it is desirable to provide a mechanical means by which waste discharge can be managed. One way to do this is to temporarily seal the stoma opening so as to prevent discharge when the seal is present. Once the seal is removed, evacuation of the bowel can take place.
However, an important concern in the management of stomas is to avoid exerting excess local pressure on the mucosal tissue. High local pressure can damage the stoma. Further, it can prevent blood flow to the tissue if the applied pressure exceeds capillary pressure. Thus, any acceptable evacuation control device must seal the stoma exerting harmful pressure on the stoma or surrounding tissue.
The seal, which forms the subject of the invention, is designed to be mounted externally and to exert a low pressures (preferably between 10 mm Hg and 30 mm Hg) across the entire face of the stoma. The seal itself is formed of a thin and flexible membrane. The membrane is preferably made of a material with good barrier properties. One possible candidate material is the film used in the manufacture of ostomy pouches. Under a minimal amount of external pressure, the membrane drapes itself across and around the stoma, covering most surface irregularities. Based on preliminary laboratory test results, the device can prevent release of stool from the bowel with internal bowel pressure of 50 mm Hg and above.
Such a seal would adapt itself to a variety of stoma sizes and shapes. It would also be, by design, a slightly xe2x80x9cimperfectxe2x80x9d seal, so that it would block the release of solid or semi-solid matter but would allow gas to escape. The ability of the seal to permit gas to escape is important to the management of waste in the bowel, since at any given time more than two-thirds of the volume in the bowel is gas. Releasing gas in a controlled way minimizes discomfort and maximizes the time between evacuations.
The tissue surrounding the stoma may be very sensitive. It is therefore also important that only minimal activation pressure be required to create the seal.
Further, it is desirable that the sealing device be interchangeable with a standard two-piece ostomy device collection pouch. In this way, the sealing device can be coupled to a standard two-piece ostomy device collection pouch. In this way, the sealing device can be coupled to a standard two-piece ostomy device faceplate, eliminating the necessity of removing an appliance that is adhesively attached to the skin after each evacuation and hence the damage to the skin inherent in such repeated removals.
It is, therefore, a prime object of the present invention to provide a controlled evacuation ostomy device which includes an external seal.
It is another object of the present invention to provide a controlled evacuation ostomy device with an external seal which exerts a minimum amount of sealing pressure on the mucosal tissue.
It is another object of the present invention to provide a controlled evacuation ostomy device with an external seal which permits the release of gas from the bowel while preventing the discharge of solid or semi-solid materials.
It is another object of the present invention to provide a controlled evacuation ostomy device with an external seal which requires minimum pressure to create the seal.
It is another object of the present invention to provide a controlled evacuation ostomy device with an external seal which is compatible with standard two-piece ostomy devices.
In accordance with one aspect of the present invention, an ostomy device is provided including a thin, flexible membrane. Means are provided for securing the membrane to the tissue surrounding the stoma. Means are also provided for pressing the membrane against the stoma to seal the stoma.
The membrane has an edge. The securing means includes an adhesive layer on the membrane edge.
The pressing means includes a member situated over and sealed to the membrane. The member and the membrane define an internal chamber. The chamber can be pressurized to press the membrane against the stoma. Means are provided for pressurizing the internal chamber.
In accordance with another aspect of the present invention, an ostomy device is provided including a member formed of a wall with an edge. Means are provided for adhering the edge of the wall to the tissue surrounding the stoma. Sealing means are situated within member, proximate the stoma. The sealing means has a first surface and a second surface. The sealing means defines a chamber within the member interior, between its first surface and the wall. The chamber can be pressurized to press the second surface of the sealing means against the stoma.
The sealing means comprises a flexible membrane. The membrane has an edge. The membrane edge is fixed to the interior surface of the member. The membrane also preferably includes one or more circumferential pleats.
The device includes means for pressurizing the chamber. The pressurizing means includes means in the member wall for permitting the entrance of fluid, such as air, into the chamber. The entrance means includes an inlet port and a one way valve.
The pressurizing means may include an external pump device. Alternatively, it may include a pump device integral with the member.
The integral pump device includes a flexible wall affixed to the member. The flexible wall defines a chamber external to the member. The volume of the external chamber can be reduced by the application of pressure on the flexible wall. The entrance port connects the external pump cavity and the internal chamber of the member.
Means are provided for limiting the pressure introduced into the internal chamber of the member. The pressure limiting means includes a pressure relief valve.
The sealing means defines a second internal chamber between its second surface and the member wall. Means are provided for venting the second internal chamber. The venting means includes an outlet port.
The venting means may also include gas filtration means. The filtration means includes a filter element operatively imposed between the second internal chamber and the outlet port. Any one of a variety of activated carbon filter formulations and constructions, including the use of protective microporous membranes, can be considered appropriate for use in this regard.
The member wall edge sealing means includes means for engaging the edge of the member wall and means for adhering the edge engaging means to the tissue surrounding the stoma. The edge engaging means may include means for removeably engaging the edge of the member.
The device may be designed for use in combination with waste collection means, such as a waste collection pouch. The waste collection means is situated between the member wall and the edge sealing means. The waste collection means may be collapsible, preferably with a concertina-like configuration.
The waste collection means may include a collection pouch with first and second flexible walls sealed around the periphery. The walls are fixed between the member and the edge sealing means, respectively.
The collection pouch may be elongated. Means for storing the pouch proximate the member may be provided.